Rehabilitation Approaches for Shoulder Pain

Overseen By Abigail Anderson

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Central Florida

Disqualifiers: Non-English, Uncontrolled diabetes, Hemophilia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore different methods to alleviate shoulder pain and enhance daily activities. Participants will receive one of two treatments: a tissue-focused approach, which includes exercises and comfort tips, or a biopsychosocial approach, which combines pain education and stress management with exercises. This trial suits individuals with shoulder pain rated at 3 out of 10 or higher who are not currently receiving physical therapy for this issue. As an unphased trial, it offers a unique opportunity to explore innovative treatments for shoulder pain.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both mind-body and physical treatments for shoulder pain are safe. For the mind-body treatment, studies indicate it can help manage shoulder pain by focusing on the mind-body connection. Some evidence suggests it can shorten the duration and lessen the intensity of pain, though proof of its overall effectiveness when combined with other treatments is limited. No serious side effects have been reported, indicating it is generally well-tolerated.

The physical treatment involves learning and exercises to relieve shoulder pain. Reviews of similar physical therapy treatments have shown they are safe and can reassure patients by teaching them that their condition isn't serious. These treatments are considered safe, with some evidence suggesting they improve pain sensitivity and shoulder function over time.

Both approaches are generally well-tolerated, with no major safety concerns noted in past research. Participants can expect a focus on learning, exercise, and the mind-body approach to help reduce shoulder pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for shoulder pain because they focus on a holistic approach rather than just physical therapy or medication alone. The biopsychosocial intervention uniquely combines pain education and stress management with physical exercises, addressing both mind and body. Meanwhile, the tissue intervention emphasizes educating patients on safe movements and gradually increasing activity levels, which might speed up recovery and enhance daily function. These approaches aim to offer a more comprehensive recovery strategy compared to traditional treatments that often focus solely on physical symptoms.

What evidence suggests that this trial's treatments could be effective for shoulder pain?

This trial will compare two different rehabilitation approaches for shoulder pain. The Biopsychosocial Intervention, one of the study arms, combines physical treatment with education about pain and stress management. Research has shown that this approach, addressing both the physical and mental aspects of pain, can improve pain management and understanding of the condition, leading to better overall results.

The other study arm, the Tissue Intervention, focuses on treatments aimed at the body. Studies have found that exercises and learning the correct way to move can help with pain and shoulder function. Some reviews suggest that these physical therapies can improve shoulder movement and reduce pain in the short term. Reducing tendon thickness, a goal of this approach, is linked to better shoulder health. Overall, both types of treatment in this trial show promise in reducing shoulder pain and improving function. ^{6 7 8 9 10}

Who Is on the Research Team?

Abigail Anderson

Principal Investigator

University of Central Florida

Are You a Good Fit for This Trial?

This trial is for individuals experiencing shoulder pain with an intensity of at least 3 out of 10 in the past day. Specific eligibility details are not fully listed, but typically participants would need to meet certain health criteria.

Inclusion Criteria

My shoulder pain has been 3 or more out of 10 in the last day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a tissue-based intervention or a biopsychosocial intervention over eight sessions

4 weeks

8 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biopsychosocial Intervention
• Tissue Intervention

Trial Overview

The study compares two treatments for shoulder pain: a tissue-based intervention (likely involving physical therapy or similar techniques) and a biopsychosocial intervention (which considers psychological and social factors along with biological).

How Is the Trial Designed?

Group I: Tissue Intervention Experimental Treatment 1 Intervention

Participants will attend eight sessions. During each session, participants will receive education on positions of comfort, progressing activities, and return to function. Participants will complete shoulder stretching and strengthening exercises according to a protocol.

Group II: Biopsychosocial Intervention Active Control 1 Intervention

Participants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol.

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

Published Research Related to This Trial

A systematic review of multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain found only 2 relevant studies, both of which had low methodological quality, indicating a lack of strong scientific evidence for its effectiveness.

Despite being widely used, the review concluded that there is limited evidence supporting the efficacy of these rehabilitation programs compared to other treatment options, highlighting the need for higher quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain among working age adults. Karjalainen, K., Malmivaara, A., van Tulder, M., et al.[2018]

There is moderate evidence that multidisciplinary rehabilitation programs, which include workplace visits, can effectively help working-age adults with subacute low back pain return to work faster and reduce sick leave.

Only two relevant studies were found, both of which had low methodological quality, highlighting the need for more rigorous research to confirm the effectiveness of these rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary biopsychosocial rehabilitation for subacute low back pain among working age adults. Karjalainen, K., Malmivaara, A., van Tulder, M., et al.[2018]

Multidisciplinary pain management programs that use a biopsychosocial approach can lead to significant pain reduction and improvements in quality of life and psychosocial functioning.

Successful outcomes, including return-to-work and vocational improvements, depend on effective communication and collaboration among a diverse treatment team, which may include various healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary and interdisciplinary management of chronic pain. Stanos, S., Houle, TT.[2022]

Physical therapist-led interventions based on the biopsychosocial (BPS) model significantly reduce pain intensity in patients with spinal disorders, showing clinically meaningful effects in the short and medium term, with standardized mean differences of -0.44 and -0.24, respectively.

These BPS model interventions also effectively decrease disability in patients, with significant improvements observed across all time frames (short, medium, and long term), indicated by standardized mean differences of -0.48, -0.44, and -0.37, although the overall quality of evidence was low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapist-led interventions based on the biopsychosocial model provide improvement in disability and pain for spinal disorders: A systematic review and meta-analysis. Miki, T., Kondo, Y., Kurakata, H., et al.[2023]

In a study of 78 patients with atraumatic shoulder pain, those who showed clinical improvement after 3 months of nonoperative treatment had significantly higher self-efficacy scores, suggesting that belief in their ability to manage symptoms plays a crucial role in recovery.

Patients who improved reported lower pain levels compared to those who did not improve, indicating that enhancing self-efficacy may be an important strategy in managing shoulder pain effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of self-efficacy on nonoperative treatment of atraumatic shoulder pain. Grandizio, LC., Choe, LJ., Follett, L., et al.[2022]

The biopsychosocial approach is effective for managing chronic pain by integrating education, cognitive-behavioral therapy, and relaxation techniques, helping patients control their thoughts and emotions related to pain.

This approach not only addresses the psychological and social factors of pain but also complements traditional medical care, making it a comprehensive treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial therapies for neck pain. Victor, L., Richeimer, SM.[2019]

A systematic review of multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain found only two relevant studies, both of which had low methodological quality, indicating a lack of robust evidence for its effectiveness.

Despite being widely used, the review concluded that there is limited scientific support for the efficacy of these rehabilitation programs compared to other treatment options, highlighting the need for higher quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain among working age adults. Karjalainen, K., Malmivaara, A., van Tulder, M., et al.[2022]

The study developed 51 process indicators to evaluate how well manual physical therapists (MPTs) take biopsychosocial histories in patients with chronic back and neck pain, revealing that while somatic history taking was excellent (98.3%), psychological and social dimensions were inadequately addressed, with scores as low as 18.2%.

There was a significant gap between MPTs' self-assessment and actual performance, as they believed they were adequately covering psychological aspects, while the data showed much lower effectiveness, highlighting the need for improved training in biopsychosocial approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual physical therapists' use of biopsychosocial history taking in the management of patients with back or neck pain in clinical practice. Oostendorp, RA., Elvers, H., Mikołajewska, E., et al.[2018]

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